HOMEPRODUCTSSERVICESCOMPANYCONTACTFAQResearchDictionaryPharmaMobileSign Up FREE or Login

Immunogenicity and safety of hepatitis B vaccine (Shanvac-B) using a novel pre-filled single use injection device Uniject in Indian subjects.

AbstractBACKGROUND:
Hepatitis B is a major public health problem, which has now been controlled to some extent by vaccination especially with the recombinant hepatitis B vaccine, which has been proven to be safe and efficacious since its introduction in the 1990s. But problems of unsafe injection practices still persist. Now newer delivery devices like uniject are available for making vaccination very safe.
OBJECTIVE:
To evaluate the immunogenicity and safety of the Hepatitis-B (Shanvac-B) vaccine in Uniject pre-filled device administered to healthy adults and infants at 0, 1, 2 months schedule.
METHODS:
A total of 122 healthy subjects (62 adults and 60 infants) were administered three doses of the recombinant Hepatitis-B vaccine using Uniject pre-filled device. Blood samples for antibody titer estimation were taken before vaccination and 4-6 weeks after third dose. Subjects, parents or guardians were given diary cards to record any adverse reactions.
RESULTS:
Protective immune responses to the vaccine were seen in 96.4% of adults and 100% of infants who completed the study. The Geometric Mean Titers (GMT) in adults and infants were 518.5 and 385.41 mIU/ml respectively. Mild fever, itching, and swelling at injection site were the most common side effects observed.
CONCLUSION:
The safety and immunogenicity of the Hepatitis B Vaccine in the novel pre-filled device Uniject was effectively demonstrated in the present study.
AuthorsN Joshi, A Kumar, M B Raghu, S Bhave, R Arulprakash, P Bhusari, Raman Rao
JournalIndian journal of medical sciences (Indian J Med Sci) Vol. 58 Issue 11 Pg. 472-7 (Nov 2004) ISSN: 0019-5359 [Print] India
PMID15567904 (Publication Type: Comparative Study, Journal Article)
Chemical References
  • Hepatitis B Vaccines
Topics
  • Adolescent
  • Adult
  • Cohort Studies
  • Disease Transmission, Infectious (prevention & control)
  • Drug Packaging
  • Equipment Safety
  • Female
  • Hepatitis B (prevention & control)
  • Hepatitis B Vaccines (administration & dosage, immunology)
  • Humans
  • Immunization Schedule
  • India
  • Infant, Newborn
  • Injections, Subcutaneous
  • Male
  • Middle Aged
  • Sensitivity and Specificity
  • Vaccination (instrumentation, methods)

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research network!


Choose Username:
Email:
Password:
Verify Password: